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yoyo88

10/01/13 11:09 AM

#15222 RE: sts66 #15196

Since you posted this, I'm sure you have seen the news and confirmations by several (including AF) to the contrary.
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KCSVEN

10/01/13 11:17 AM

#15224 RE: sts66 #15196

Per FDA looks like they will be going forward with PDUFA, still not 100% clear on Adcomm based on this info but others seem to be reporting Adcom will go on also.

10/1/2013]
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With respect to medical product user fees, during the lapse period, FDA will not have legal authority to accept user fees assessed for FY 2014 until an FY 2014 appropriation for FDA is enacted. This will mean that FDA will not be able to accept any regulatory submissions for FY 2014 that require a fee payment and that are submitted during the lapse period.
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wmjenkins3938

10/01/13 1:17 PM

#15236 RE: sts66 #15196

Why would user fees cover everything except the items you mentioned?